 NEW TRENDS? BACK TO TOP
This week, PFIZER received approval of Viagra for the
treatment of male impotency. The New York Times said it should have sales in the
billions. Last year, MERCK received approval for
finastride for the treatment of hair loss. While there are many new products in the
pipeline for the treatment of life-threatening diseases, we are now seeing the birth of a
new philosophy in drug development; drugs specifically targeting Quality of Life. Non
life-threatening diseases can have a marked effect on one's well being and mental
status. The psychological effects of impotency, acne and hair loss can affect
relationships, productivity and self-esteem. It is time that psychological as well
as physiological factors are considered when evaluating drug candidates. TARGET HEALTH is pleased to announce that it is
working on several Quality of Life projects with NDA tracks and worked closely with the
Viagra outcomes group at PFIZER.
- NATURAL PRODUCTS BACK TO TOP
In was recently reported in The Journal of the National Cancer Institute that Vitamin E
reduced the risk of prostate cancer by a third and the disease's death rate by 41 percent
in a study of thousands of smokers. The study also showed that a form of vitamin A had no
effect on reducing cancer. In fact, the data suggest that beta carotene users in the
study were about 16 percent more likely to develop lung cancer. This result, first
reported three years ago, startled many who had expected beta carotene to be proved as a
cancer preventive. It was also suggested that vitamin E, in the form of alpha tocopherol,
might provide some protection against colorectal cancer and, after five years, some
protection against lung cancer, although these data were not nearly as dramatic as the
prostate cancer results.
Natural products are here to stay. At TARGET HEALTH
we have begun exploring concepts as to how to patent and market natural products
with medicinal claims.
The study, performed in Finland, involved 29,133 male smokers, ages 50 to 69, who had been
selected to take part in a lung cancer study evaluating the effect of beta carotene and
vitamin E on smokers. The men were divided into four groups. One group took beta
carotene supplements; another took vitamin E; a third took a combination of the two, while
the last group took only a placebo. The vitamin E dosage was 50 milligrams a day,
which is the equivalent of 50 international units. This is about five times the
recommended minimum daily intake for men and about two and one-half times what most people
get from food. After five to eight years on the supplements, 14,564 men taking
vitamin E alone or with beta carotene had 32 percent fewer cases of prostate cancer than
the 14,569 who did not take vitamin E. Also, there were 41 percent fewer prostate
cancer deaths among men taking vitamin E. Taking the vitamin E supplement was not
risk-free. Among those taking the vitamin, there were 66 deaths from the cerebral
hemorrhage, or bleeding, type of stroke, compared with 44 such deaths among the men not
taking vitamin E.
Foods rich in vitamin E include vegetable oils, particularly those from safflower,
sunflower and cotton seeds; wheat germ and whole grains, and whole nuts, like
almonds. However, to get 50 international units of vitamin E from such foods would
mean taking in a great deal of extra dietary fat, which may not be beneficial.
- SALMONELLA BACK TO TOP
Salmonella is one of the leading causes of food-borne illness and about 20 percent of
chickens are infected with it. Incidents of food-borne illnesses are difficult to
track and often go unreported, but public health officials estimate that there are between
800,000 and 4 million cases of salmonellosis a year in the United States and 960 to 1,920
deaths. The new technique, which was approved this week by the FDA, significantly
reduces salmonella in chickens by providing protection that, before factory farming, was
naturally transferred from a mother hen to her chicks. The product, called CF-3 or
Preempt, is a mixture of beneficial microbes that occur naturally in chicken. If the
technique proves successful, it could also reduce the use of antibiotics in chicken, a
practice which has contributed to an increase in drug-resistant bacteria. Preempt
also may prove beneficial in reducing or eliminating campylobacter, which is far more
prevalent in chickens than salmonella and is responsible for many more illnesses.
Preempt, developed by Agriculture Department scientists and MS BIOSCIENCE, a division of
Milk Specialties Co. of Dundee, Ill., involves spraying newly hatched chicks with a
solution that contains 29 beneficial bacteria. The birds peck their wet feathers and
ingest the bacteria, which begin to grow inside the chicks' intestines. Any
salmonella ingested later cannot compete with the "good bacteria" and thus
passes harmlessly through the intestines. In tests involving 80,000 chickens, the Preempt
spray reduced salmonella from about seven percent in untreated chickens to zero percent in
the intestines of the treated chickens. But salmonella was still detected in the
chicken houses and there have been no studies of salmonella levels in chickens treated
with Preempt after they have been processed. Dr. Donald Corrier, a veterinary
pathologist for the Department of Agriculture and the project leader for Preempt, cautions
that even though the product can reduce contamination "to produce a cleaner chicken
there is a need for an integrated program that carries all the way through the process
from farm to store. For Preempt to be beneficial requires cooperation in all parts of the
industry." Proper sanitation from farm to supermarket is still essential.
TARGET HEALTH is working closely with a
client to develop a product to extend the shelf-life of meats and poultry. The data
look very interesting and a meeting with the FDA and USDA has already taken place.
- FDA
BACK TO TOP
Women's HEALTH is an area in which TARGET HEALTH
has three active NDA and PMA projects at the FDA. Therefore, it is with interest that we
share a recent program to be launched by FDA this month.
With 30 to 50 percent of Americans not taking their medications as prescribed, and the
annual cost of preventable medicine-related illness estimated to be $76.6 billion, the FDA today launched
a nationwide campaign to educate women about the importance of properly using
medicines. The grassroots campaign, Women's HEALTH: Take Time to Care,
"Use Medicines Wisely" is primarily directed at women over 45, particularly
those who are under-served. The focus is specifically on women because they often
manage medications for their entire family as well as themselves. The campaign will
help women learn more about important medication issues, including preventing interactions
between drugs, following usage instructions, keeping track of medication regimens and
getting professional advice. "In many households, women are the primary
caregivers for their children and, increasingly, their own parents. Often their own
health is overlooked in the process," said Donna E. Shalala, Secretary of DHHS.
"By taking time to learn to use medicines wisely, women will be able to take better
care of themselves and their families."
The campaign's goal is to bring home the fact that medicines usually work best when taken
as prescribed." The FDA Office of Women's HEALTH has partnered with the
National Association of Chain Drug Stores, and a broad network of consumer organizations,
women's groups, health care providers, health institutions and government agencies to
develop the "Take Time to Care" campaign. These organizations include the
League of Women Voters, American Heart Association, National Black Nurses Association, and
American Association for Retired Persons. The public awareness campaign will include
a tour of fifteen cities, beginning in San Francisco on March 21, where workshops and
other community activities are being planned. FDA also plans to bring the program to rural
communities and Indian reservations in cooperation with the U.S. Department of Agriculture
and the Indian HEALTH Service.
|
